Hiren Patel

Associate Director CMC submission Management @ Takeda

About

Experienced with Regulatory Submissions and a demonstrated history of work in the pharmaceutical industry. Proficient with FDA guidance, ICH Guideline, Quality, Multidisciplinary Regulatory Affairs Frame. (US-FDA, EU, Health Canada, TGA, JNDA). Master's degree focused in International Regulatory Affairs at Northeastern University. Knowledge of Regulatory Submissions that involve IND, NDA/BLA, CMC components, QC, ANDA, Prepare Amendments and Supplements Associated with Existing Applications. Ensuring Compliance with FDA and International Regulations. Suggesting and Implementation of Corrective and Preventive Action (CAPA) for non-compliance issues. Preparation of Regulatory Templates for NDA/BLA, MAA, ANDA, JNDA. Strong understanding on Medical Devices - 510(K), PMA, IDE, Devices Manufacturing QSR according to US-FDA, Medical Device Reporting, Device Recalls. Preparation of Regulatory Templates of Clinical Synopsis, Clinical Monitoring plans, Case Report Forms, Informed Consent Forms.

Country

United States

City

Boston

Industry

Pharmaceuticals

Skill

Dossier Preparation, Regulatory Submissions, Production Management, Plant Operations, Budgeting, Manufacturing Operations, CMC Regulatory Affairs, Project Management, Microsoft Project, Strategic Communications, Team Management, Subject Matter Experts, Strategic Thinking, Regulatory Agencies, Project Teams, Conflict Resolution, Clinical Trials, Infectious Diseases, Public Health, Drug Development

Experience

Associate Director CMC submission Management

Takeda

2025-11 - Present · 11 mos

Cambridge, Massachusetts, United States

Senior manager Global Regulatory Affair CMC Submission Management

Takeda

2022-9 - 2025-11 · 3 yrs 3 mos

Cambridge, Massachusetts, United States

• Led NDA/MAA eCTD dossier filings submissions and Responses to Health Authority inquiries, resulting in successful BLA/NDA approvals in major countries. • Managed development of IND/CTA, IMPD submissions, ensuring compliance with global regulations. • Negotiated timelines with SMEs/authors, compiled submission components, and drove all deliverables against the timeline.

Manager Global Regualtory Affair CMC Submission

Takeda

2020-3 - 2022-9 · 2 yrs 7 mos

United States

• Led submission management activities for Developmental products from early phase to approval, ensuring timely preparation per Takeda quality standards. • Managed third-party Publishing and CRO teams, negotiating timelines to meet deliverables for US and Global Markets. • Partnered with CMC Regulatory Lead to translate regulatory development strategy into operational plans. • Executed and led the RTQ Process for assigned projects.

Regulatory Affairs & Quality Assurance (RAQA)

Tarveda Therapeutics

2019-7 - 2020-2 · 8 mos

Watertown, MA

• Drafted cover letters and FDA forms, authored CMC M2 & M3 sections, and reviewed documents for submission to regulatory authorities. • Maintained compliance with FDA, CGMP, and 21CFR regulations at Tarveda Therapeutics in Watertown, MA. • Assisted in the preparation of audits and publishing activities for Syneos Health.

Production Supervisor

Viva Pharmacy Inc

2016-4 - 2018-8 · 2 yrs 5 mos

Richmond, British Columbia, Canada

• Supervised and coordinated production activities at Viva Pharmacy Inc in Richmond, BC, ensuring adherence to GMP regulations and safety protocols. • Prioritized work assignments based on client delivery requirements and equipment availability, optimizing production efficiency. • Collaborated with QA/QC, R&D teams for product formulation and process methodology, enhancing product quality and innovation. • Managed production line and supported machine settings, ensuring smooth production maintenance as per plant facilities SOPs.

Pharmaceutical Production Worker

Viva pharmaceutical Inc

2015-10 - 2016-3 · 6 mos

Richmond, British Columbia, Canada

• Operated Tablet Machine, Mixture, Double Cone, Capsule Filling Machine • Assured daily Production Schedule is Completed • Established All Products are Built to the Highest Standard of Quality • Checked the Quality of Prepared Product and Documenting the Exact Results at Precise Times During the Production Process • Ensured All Equipment’s is Cleaned and sanitize in the Plant Processing Area